Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Dec 25;29(6):385-388.
doi: 10.11919/j.issn.1002-0829.217163.

Comparisons of Superiority, Non-inferiority, and Equivalence Trials

Bokai Wang  1 , Hongyue Wang  1 , Xin M Tu  2 , Changyong Feng  1   3
Affiliations

Comparisons of Superiority, Non-inferiority, and Equivalence Trials

Bokai Wang et al. Shanghai Arch Psychiatry. .

Abstract
in English, Chinese

Efficacy of a new drug or treatment is usually established through randomized clinical trials. However, specifying hypotheses remains a challenging problem for biomedical researchers. In this survey we discuss superiority, non-inferiority, and equivalence trials. These three types of trials have different assumptions on treatment effects. We compare the assumptions underlying these trials and provide sample size formulas.

一种新型药物或治疗的效果通常是通过临床随机对照试验获得的。然而，假设的设定对生物医学研究者来说仍然是具有挑战性的问题。在本调查中，我们讨论了有效性试验、非劣效性试验、和等效性试验。这三类试验对治疗效果均有不同的假设。我们比较了这些试验中的假设并提供了样本量计算公式。.

Keywords: Randomized clinical trial; margin of clinical significance; sample size calculation.

PubMed Disclaimer

References

    1. Chow SH, Liu JP. Design and analysis of clinical trials (2nd ed.). Hoboken, NJ: Wiley; 2004
    1. Christensen E. Methodology of superiority vs. equivalence trials and non-inferiority trials. J Hepatol. 2007; 46: 947-954. doi: http://dx.doi.org/10.1016/j.jhep.2007.02.015 - DOI - PubMed
    1. Dunnett CW, Gent M. An alternative to the use of two-sided tests in clinical trials. Stat Med. 1996; 15: 1729-1738. doi: http://dx.doi.org/10.1002/(SICI)1097-0258(19960830)15:16<1729::AID-SIM33... - DOI - PubMed
    1. Fleshner NE, Evans A, Chadwick K, Lawrentschuk N, Zlotta A. Clinical significance of the positive surgical margin based upon location, grade, and stage. Urol Oncol. 2010; 28(2): 197-204. doi: https://doi.org/10.1016/j.urolonc.2009.08.015 - DOI - PubMed
    1. Friedman LM, Furberg CD, DeMets D, Reboussin DM, Granger CB. Fundamentals of clinical Trials (5th ed.). New York: Springer; 2015

LinkOut - more resources